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Endoscopic Third Ventriculostomy for Adults: A Prognostic Model for Success

NCT04773938 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2022-05-03

No results posted yet for this study

Summary

Endoscopic Third Ventriculostomy for Adults with Hydrocephalus: Creating a Prognostic Model for Success - A Retrospective Multicenter Study

Background: Endoscopic third ventriculostomy (ETV) is becoming an increasingly widespread treatment for hydrocephalus, but most of the research is based on paediatric populations. The ETV Success Score (ETVSS) was developed in 2009 to predict the outcome of ETV in children. There is no similar tool for predicting outcome in adults.

Objective: The purpose of this study is to create a prognostic model to predict the success of ETV for adult patients with hydrocephalus

Methods: The study will adhere to the TRIPOD reporting guidelines and will be conducted as a retrospective chart review of all patients ≥18 years old treated with ETV at the participating centres between Jan 1st, 2010 and Dec 31st, 2018. Data collection is conducted locally in REDCap. Univariate analyses will be used to identify several strong predictors to be included in a multivariate logistic regression model. The model will be validated using K-fold cross validation. Discrimination will be assesses using AUROC and calibration with calibration belt plots.

Expected outcomes: The ability to predict who will benefit from an ETV will allow better primary patient selection both for ETV and shunting. This would reduce additional second procedures due to primary treatment failure. A success score specific for adults could also be used as a communication tool to provide better information and guidance to patients.

Conditions

  • Hydrocephalus

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Sondre Tefre · Department of Neurosurgery, Copenhagen University Hospital Rigshospitalet

  • Marianne Juhler · Department of Neurosurgery, Copenhagen University Hospital Rigshospitalet

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-27
Primary Completion
2022-06-30
Completion
2022-08-31

Countries

  • Denmark
  • Finland
  • Norway
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04773938 on ClinicalTrials.gov